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Neomycin Sulfate topical

Pronunciation

Class: Antibacterials
VA Class: DE101
CAS Number: 1405-10-3
Brands: Bactine First Aid Antibiotic Plus Anesthetic, Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength, Mycitracin Plus Pain Reliever, Mycitracin Triple Antibiotic First Aid, Neo-Rx, Neosporin, Neosporin G.U. Irrigant, Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving, Spectrocin, Triple Antibiotic, Triple Antibiotic Extra, Triple Antibiotic Plus, Triple Antibiotic With Lidocaine

Introduction

Aminoglycoside antibiotic.a

Uses for Neomycin Sulfate

Superficial Skin Infections

Topically (in combination with other anti-infectives) to prevent or treat superficial skin infections caused by susceptible organisms.a

May be useful for preventing infection in minor skin injuries (e.g., cuts, scrapes, burns).a

Role of topical anti-infectives for treatment of superficial skin infections has not been fully elucidated.a

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Self-medication with topical anti-infectives to treat superficial skin infections currently is not recommended.a

Treatment of serious or extensive skin infections usually requires systemic anti-infective therapy.a

Bacteriuria and Bacteremia Associated with Indwelling Catheters

Short-term (≤10 days) continuous irrigation of the urinary bladder to prevent bacteriuria and septicemia (due to gram-negative bacilli) associated with use of indwelling catheters.b

Instillation/Irrigation

Has been used for peritoneal instillation and for irrigation of wounds or surgical sites; no longer recommended for these uses because severe toxicity may occur.a (See Toxicity under Cautions.)

Neomycin Sulfate Dosage and Administration

Administration

Topical Administration

Apply ointment or cream topically to cleansed area.a

May cover affected area with a sterile bandage following use of ointments or creams.a

Do not apply to the eye.c d

Do not apply over large areas of the body.c d

Bladder Irrigation

Intended for continuous irrigation of the lumen of an intact urinary bladder in patients with indwelling catheters; use under constant supervision by a clinician.b

Administer via a 3-way catheter.b

Important that the irrigation is continuous; the inflow should not be interrupted for more than a few minutes.b

Neomycin sulfate and polymyxin B sulfate solution for irrigation is not for injection.b

Dilution

Add 1 mL of commercially available urogenital solution containing 57 mg of neomycin sulfate and 200,000 units of polymyxin B sulfate to 1 L of 0.9% sodium chloride solution.b

Rate of Administration

1 L every 24 hours (approximately 40 mL/hour).b Adjust the inflow rate to 2 L every 24 hours if the patient’s urine output exceeds 2 L/day.b

Dosage

Available as neomycin sulfate; dosage expressed in terms of the salt or the base.b c d

Pediatric Patients

Superficial Skin Infections
Topical

Children ≥2 years of age: Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.c d

Adults

Superficial Skin Infections
Topical

Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.c d

Bacteriuria and Bacteremia Associated with Indwelling Catheters
Bladder Irrigation

1 L of a solution containing 57 mg of neomycin sulfate and 200,000 units of polymyxin B sulfate in 0.9% sodium chloride solution every 24 hours.b Adjust the inflow rate to 2 L every 24 hours if the patient’s urine output exceeds 2 L/day.b Administer for ≤10 days.b

Prescribing Limits

Pediatric Patients

Superficial Skin Infections
Topical

Maximum 1 week of use unless directed by a physician.b c

Adults

Superficial Skin Infections
Topical

Maximum 1 week of use unless directed by a physician.b c

Bacteriuria and Bacteremia Associated with Indwelling Catheters
Bladder Irrigation

Maximum 10 days.b

Cautions for Neomycin Sulfate

Contraindications

  • Known hypersensitivity to neomycin or any ingredient in the formulation.b c d

  • Bladder irrigation: History of hypersensitivity or serious toxic reaction to an aminoglycoside.b

Warnings/Precautions

Warnings

Appropriate Use of Neomycin Sulfate and Polymyxin B Sulfate Solution for Irrigation

For bladder irrigation only.b

Do not use if systemic absorption possible.b

Topical application to open wounds, burns, and granulation surfaces associated with substantial systemic absorption and risk of toxicity.b (See Toxicity under Cautions.)

Irrigation of an intact urinary bladder for ≤10 days is not expected to result in clinically important systemic absorption.b Absorption of neomycin from denuded bladder surface reported.b

Avoid in patients with defects in the bladder mucosa or bladder wall (e.g., vesical rupture); do not use in conjunction with operative procedures on the bladder wall.b Systemic absorption possible; risk of toxicity.b

Safety and efficacy in patients with recent lower urinary tract surgery not established.b

Sensitivity Reactions

Topical neomycin is a contact sensitizer, especially when used for prolonged periods.a Contact dermatitis, burning, erythema, rash, and urticaria reported following topical application.a

If irritation or hypersensitivity occurs, discontinue use and consult a clinician.a

Patch testing (e.g., 20% neomycin sulfate in petrolatum) may be useful in diagnosing allergic contact dermatitis to the drug.a

Anaphylactoid reactions reported rarely with topical application.a

Major Toxicities

Toxicity

Ototoxicity, nephrotoxicity, and neuromuscular blockade reported following topical application of neomycin, especially in patients undergoing peritoneal instillation, irrigation of wounds or surgical sites, or those receiving treatment for skin ulcers, granulating wounds, burns, or extensive areas of denuded skin.a Death reported rarely.a (See Appropriate Use of Neomycin Sulfate and Polymyxin B Sulfate Solution for Irrigation under Cautions.)

Application to large areas of abraded skin in infants with diaper rash could result in substantial absorption, especially since the diaper may act as an occlusive dressing.a

Use with caution for treatment of extensive burns, trophic ulceration, or other extensive dermatological condition where rapid absorption of the drug is possible.a

Risk of toxicity highest in patients with renal impairment, infants, dehydrated individuals, geriatric individuals, and patients receiving high doses for prolonged periods.b

General Precautions

Superinfection

Overgrowth of nonsusceptible organisms, particularly fungi, may occur; institute appropriate therapy if superinfection occurs.a b

Use of Fixed Combinations

When neosporin is used in fixed-combination with other drugs, observe the cautions and precautions of the other drugs.b c d

Corticosteroids in topical anti-infective combination preparations may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotics or other ingredients in the formulations; weigh benefits against risks.a

Specific Populations

Pregnancy

Category C.e

Bladder irrigation: Category D.b

Lactation

Clinically unimportant amounts of neomycin may distribute into breast milk.e

Pediatric Use

Bladder irrigation: Safety and efficacy not established in pediatric patients.b

Ointments/creams for self-medication: Suitable for children ≥2 years of age.c d

Risk of toxicity increased in infants.b (See Toxicity under Cautions.)

Geriatric Use

Bladder irrigation: Risk of toxicity increased in geriatric patients.b (See Toxicity under Cautions.)

Renal Impairment

Bladder irrigation: Risk of toxicity increased in patients with renal impairment.b (See Toxicity under Cautions.)

Common Adverse Effects

Local or systemic hypersensitivity reactions, irritation of the urinary bladder mucosa.b

Neomycin Sulfate Pharmacokinetics

Absorption

Bioavailability

Not absorbed to any appreciable extent from intact skin.a Readily absorbed through denuded or abraded areas of skin or skin that has lost the keratin layer (i.e., wounds, burns, ulcers).a Rapidly absorbed from the peritoneum, draining sinuses, wounds, or surgical sites.a

Plasma Concentrations

Plasma concentrations following topical application to open wounds, burns, or granulating surfaces comparable to, or higher than, those achieved following oral or parenteral administration (parenteral preparation no longer commercially available in the US).b

Stability

Storage

Topical

Cream/Ointment

Light resistant containers at 15–30°C.a

Bladder Irrigation

Solution for Irrigation

2–8°C.b

Following dilution for administration, store at 4°C; use within 48 hours.b

Actions and Spectrum

  • Usually bactericidal.a

  • Appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.a

  • Spectrum of activity includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.a

  • Gram-positive aerobes: Active against Staphylococcus aureus and S. epidermidis.a Most streptococci are resistant.a

  • Gram-negative aerobes: Active against Escherichia coli, Haemophilus influenzae, Klebsiella, Neisseria, Moraxella lacunata, and Proteus.a b Inactive against Serratia marcescensb and Pseudomonas aeruginosa.a

Advice to Patients

  • Importance of discontinuing neomycin and consulting a clinician if rash or other signs of sensitivity occur.c d

  • Importance of understanding that topical neomycin preparations are intended for external use only.c d

  • Importance of not using in the eyes or applying over large areas of the body.c d

  • Importance of first consulting a clinician when considering use for self-medication for deep or puncture wounds, animal bites, or serious burns.c d

  • Importance of discontinuing use and consulting a clinician if condition persists or worsens when used to prevent infection in minor skin injuries (e.g., cuts, scrapes, burns).c d

  • Importance of not using topical preparations for >1 week unless directed by a clinician.c d

  • Importance of patients informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of informing patients of other important precautionary information.b c d (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

 

Neo-Rx Micronized Antibiotic Powder for Prescription Compounding

Pharma-Tek

Neomycin and Polymyxin B Sulfates

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Urogenital

For irrigation, concentrate, sterile

57 mg Neosporin Sulfate (40 mg of neomycin) per mL and Polymyxin B Sulfate 200,000 units (of polymyxin B) per mL

Neosporin G.U. Irrigant (preservative-free ampuls or with methylparaben in multiple-dose vials)

Monarch

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Neomycin Sulfate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.5% (0.35% of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B), and Pramoxine Hydrochloride 1%

Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving Cream

Pfizer

Ointment

0.5% (0.35% of neomycin) with Bacitracin 400 units/g and Polymyxin B Sulfate 5000 units (of polymyxin B) per g*

Triple Antibiotic Ointment

Alpharma, Pfeiffer

0.5% (0.35% of neomycin) with Bacitracin Zinc 400 units (of bacitracin) per g and Polymyxin B Sulfate 5000 units (of polymyxin B) per g*

Neosporin

Pfizer

0.5% (0.35% of neomycin) with Bacitracin Zinc 500 units (of bacitracin) per g, Lidocaine 4%, and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g*

Bactine First Aid Antibiotic Plus Anesthetic

Bayer

Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength

Bayer

Mycitracin Plus Pain Reliever (with parabens)

J&J Consumer

Spectrocin Plus

Numark

Triple Antibiotic Extra

IVAX

Triple Antibiotic Plus Ointment Maximum Strength

Alpharma, G&W, Major

Triple Antibiotic with Lidocaine Ointment Maximum Strength

Clay-Park, Moore

0.5% (0.35% of neomycin) with Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g

Mycitracin Triple Antibiotic First Aid Ointment Maximum Strength (with parabens)

J&J Consumer

0.5% (0.35% of neomycin), with Bacitracin Zinc 500 units (of bacitracin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Pramoxine Hydrochloride 1%

Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving Ointment

Pfizer

Neomycin sulfate and anti-infective combinations including neomycin sulfate are also commercially available in combination with corticosteroids for topical use.

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

a. AHFS drug information 2004. McEvoy GK, ed. Neomycin Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2004: page 3323-4.

b. Monarch Pharmaceuticals. Neosporin G.U. Irrigant Sterile (neomycin sulfate-polymyxin B sulfate solution for irrigation) prescribing information. Bristol, TN; 1998 Oct.

c. Pfizer. Neosporin Original Ointment product information. From Pfizer web site (); assessed 2004 May 21.

d. Pfizer. Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving Cream or Ointment product information. From Pfizer web site (); assessed 2004 May 21.

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002: 983/n-4/n.

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